KaloBios Pharmaceuticals, Inc. (KBIO) reported a net loss per share of 49 cents in second quarter 2013, wider than the Zacks Consensus Estimate of a loss of 41 cents, but narrower than the year-ago loss of $1.01.
Revenues for the quarter were approximately $15,000 as compared to $3 million in the year-ago quarter. Revenues consisted entirely of contract revenues. Contract revenues declined as research support activities related to the company’s agreement with Sanofi (SNY) were completed.
Research and development (R&D) expenses were $9.6 million, above the year-ago expenses of $4.2 million. General and administrative expenses were $1.9 million, above the year-ago expenses of $0.9 million.
KaloBios is enrolling patients in a phase II study on its anti-GM-CSF mAb candidate, KB003, for the treatment of severe asthma. KaloBios anticipates top-line results in the first quarter of 2014.
The company is currently conducting a phase II study on its anti-PcrV mAb fragment, KB001-A, in cystic fibrosis (CF) patients for the prevention and treatment of chronic pseudomonas aeruginosa (Pa). For this, KaloBios received orphan drug status in the EU while the U.S. Food and Drug Administration (:FDA) has completed its review and has asked for additional information. After the completion of the ongoing phase II CF study, KaloBios will provide the FDA with additional data. Enrollment is expected to complete in mid 2014. Top-line results from the KB001-A study are expected in the fourth quarter of 2014.
The FDA has granted Fast Track designation to KB001-A to KaloBios’ partner, Sanofi, for the prevention of bacterial pneumonia caused by Pa in mechanically ventilated patients. This study is undertaken by Sanofi.
KaloBios is currently conducting a phase I study on its anti-EphA3 mAb, KB004, for the treatment of hematologic malignancies. After top-line data from this study is obtained (in the fourth quarter of 2013), KaloBios plans to start the phase II expansion phase of the study in acute myeloid leukemia (:AML) and myelodysplastic syndrome (:MDS).
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